Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Phase 2

Completed

• Conditions: Severe Ocular Surface Damage; Limbal Deficiency
• Interventions: Procedure: Cultivated limbal transplantation

• Registration Number: NCT01237600
• Lead Sponsor: Mahidol University

Brief Summary

The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

Detailed Description

Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2011-04
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result

Exclusion Criteria

• Age under 18
• Active ocular infection, Severe dry eye, Uncontrolled glaucoma
• Immunocompromised host
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cultivated limbal transplantation	Cultivated limbal transplantation	-

Primary Outcome Measures

Name	Time	Method
Ocular surface status (signs of limbal deficiency and immunopathological markers)	Three years

Trial Locations

Locations (1)

Pinnita Prabhasawat, MD; 🇹🇭 Bangkok, Thailand